Jayanta Kumar Mukhopadhyaya

San Diego, CA ***** Phone: 858-***-**** (home), 858-***-**** (cell);

Email: ad23pc@r.postjobfree.com

Clinical Research Associate/Coordinator

Professional Summary:

Dedicated, self-motivated, and reliable person with extensive experience in Clinical Trial data management, record keeping and customer service. Responsible in planning, organizing and executing clinical studies including writing IBs, Clinical Study Protocols and Protocol amendments, and IRB Documentation, and delivered quality results effectively within strict deadlines. Strong belief in open communication, teamwork and opportunities to grow.

Skill Highlights:

Strong interpersonal communication skills and ability to work effectively on cross-functional teams

High accuracy in data entry and record-keeping reporting data and test results in clinical studies

Designed CRFs, created checklists for Subject information and Consent forms, Initiation Visit, Periodic Visits, and Closeout Visit, and managed study-specific clinical supplies

Trained in using Medidata Rave and Oracle Clinical software for Clinical Data Management (CDM) from start-up to close out during clinical trials and also trained on SDTM mapping and specifications to create datasets based on CDISC Standards

Professional Experience:

Kriger Research Center, Inc., (KRC International) Jul 2023- Present

Clinical Research Professional Development Program (Practical Clinical Research Projects Intern)

Trained on Phase I/II Clinical studies:

Assisted in development of patient Informed Consent forms and prepared letters for agreements/contracts for clinical studies

Prepared final study reports and checklists for Initiation visits, Periodic visits, Close up visits

Designed and developed detailed plan of the study and timelines, research site evaluation forms, case report forms (CRFs)

Acted as the principle source of communication between the study sponsor, clinical investigators and CRO

Prepared and submitted documents required to meet regulatory, GCP and SOP requirements

Wrote and reviewed SOPs, Protocol amendments, Final Study reports

Polypeptide Group, San Diego, CA Feb 2020 - July 2023 Development Scientist

Experienced in therapeutic peptide synthesis, analytical method development, and purification processes

Entered data and maintained records with accuracy for cleaning validation

Interacted and communicated effectively with all stakeholders at each phase of execution of the project

Scheduled and attended regular team meetings for project update

Bachem, Vista, CA Dec 2014 – Jan 2020 GMP Manufacturing Chemist

Performed project-planning and initiate raw material order-request including receiving raw materials, coordinate with QA/QC and Material Management for material release and monitor raw material inventories

Wrote validation protocols and change control documents for new product and processes

Wrote deviation report, performed through investigations, identified root causes and determined corrective actions

Prepared and reviewed manufacturing batch production records and SOPs for various projects

Conventus Biomedical Solutions, Inc. San Diego, CA Apr 2012 – Dec 2014 Regulatory Affairs Scientist

Gained experience in a wide range of regulatory document preparation and submission including IND amendments, formal meeting request, meeting packages, and annual reports

Prepared briefing documents for Scientific Advisory meetings for EU and CTA template according to EMA guidance

Assisted in SPA submission and preparation of waiver request for Pediatric study plan

QC review and Regulatory archiving of all documents and correspondences

Education/Certifications:

RAC (US) Certification, Regulatory Affairs Professional Society, USA

PhD (Chemistry): Jadavpur University//Indian Association of Cultivation of Science, India

GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus-CITI program GCP certification

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